FDA to Begin Publishing Clinical Study Reports & Possibly Select CRLs

Jan. 22, 2018 | A new FDA pilot program will publish information from sponsor-produced clinical study reports (CSR) — starting with documents volunteered by companies following a drug’s approval — as part of broader agency efforts to boost transparency in clinical trials and streamline the review process.

Making CSRs publicly available will provide more clarity on the FDA’s decisionmaking process, as well as offer detail into the clinical evidence submitted in successful NDAs, ...